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OpenTrials
Completed

NCT Number: NCT00275639

The Effects of Angiotensin II Receptor Blockade on Kidney Function and Scarring After Liver Transplant

This research study is being done to study the effects, both good and bad, of calcineurin inhibitors and the drug Cozaar (losartan), on kidney function and kidney scarring following a liver transplant.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

This study is a double-blinded, placebo controlled trial to help determine the pathogenesis of chronic renal dysfunction in patients undergoing liver transplantation. It will examine the renal function and renal morphology in patients on calcineurin inhibitors and the effects of Cozaar (losartan) following liver transplantation. Participants will have blood, urine and iothalamate clearance test, to look at kidney function prior to transplant. At the time of transplant, kidney biopsies will be performed in the operating room under anesthesia. Participants will be in the study for one year. At three weeks following liver transplant, participants will be randomly assigned to receive either a placebo (inactive drug) or the study drug (losartan). The participant will need to continue to return to the clinic at the normal scheduled intervals. During these times blood and urine tests will be done. A kidney biopsy will be performed at the yearly exam and study pills will be stopped. The researchers will continue to follow participant's creatine measurements for the next 10 years.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Participants who will be undergoing a liver transplant and are between the ages of 18 to 70 years of age.

Treatment and study plan

Cozaar

Drug

Primary outcomes

  1. Development of renal dysfunction (measured by iothalamate clearance).

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

A Randomized, Double-blinded, Placebo-controlled Study of Angiotensin II Receptor Blockade to Prevent Renal Dysfunction Following Liver Transplantation.

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Jan 12, 2006
Registry last updated
Jan 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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